Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Teleflex Medical EIF-000506 - Arrow 3-Lumen Central Venous Catheters (CVC) Set

   Arrow International LLC, een dochteronderneming van Teleflex, start een vrijwillige corrigerende veiligheidsmaatregel (‘Field ...

   Waarschuwing | 24-05-2022

2. Cook Medical 2020FA0001 - Zenith Alpha Abdominal Endovascular Graft

   Met deze veiligheidskennisgeving willen wij onze klanten attenderen op een aantal aspecten van de gebruiksaanwijzing voor de ...

   Waarschuwing | 14-01-2020

3. Field Safety Notice: Cook - Zenith Alpha™ Thoracale Endovasculaire prothese

   Zoals beschreven in de recente veiligheidskennisgeving (Field Safety Notice) 2017FA0001 van maart 2017 met betrekking tot de ...

   Waarschuwing | 23-06-2017

4. Applied Medical Resources Corporation, 2027111-01/26/24-001-R, CA500, Epix UNIVERSAL CLIP APPLIER 3/BX

   Applied Medical is conducting a Field Safety Corrective Action of specific lot numbers of its Epix® Universal Clip Applier due to ...

   Waarschuwing | 18-03-2024

5. Maquet Cardiopulmonary GmbH, 881842, Cardiohelp-i

   A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was ...

   Waarschuwing | 20-11-2023

6. Maquet Cardiopulmonary GmbH, 879551, CARDIOHELP-i

   The IFU of the CARDIOHELP system states incorrect factory settings. The device itself is working as intended and the error only ...

   Waarschuwing | 10-11-2023

7. Maquet Cardiopulmonary GmbH, 881841, Cardiohelp-i

   The root cause of the improper contact originates in an incorrect drawing of the production tool in question, resulting in an ...

   Waarschuwing | 06-11-2023

8. Maquet Cardiopulmonary GmbH, 812435, Rotaflow II drive flex.compact

   In October 2022 Maquet Cardiopulmonary received a complaint on issues connected to the yellow locking mechanism unlocking on ...

   Waarschuwing | 11-07-2023

9. SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

   Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...

   Waarschuwing | 27-06-2023

10. Boston Scientific Corporation, 96993356-FA, IntellaNav StablePoint Ablation Catheter

    Boston Scientific gaat specifieke partijen van de INTELLANAV STABLEPOINT-ablatiekatheter terugroepen, doordat een foutief ...

    Waarschuwing | 11-04-2023